Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

NCT07154693 | Recruiting FDA Device

• 1 other identifier: STUDY00001531
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved. This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft.

Conditions

Tooth Extraction

Keywords

Wound healing; Vital bone; Mineralized freeze-dried bone allograft (FDBA); Demineralized freeze-dried bone allograft (DFDBA); Ridge preservation

Outcome Measures

Primary Outcomes (1)

• Percentage of Vital Bone formation

  Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation

  16 weeks

Secondary Outcomes (2)

• Percentage of Residual Graft Material

  16 weeks

• Percentage of CT/other

  16 weeks

Study Arms (2)

Osteogen Test Group

ACTIVE COMPARATOR

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Device: OsteoGen Plug

FDBA/DFDBA Control Group

ACTIVE COMPARATOR

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Device: Combination 70% FDBA and 30% DFDBA

Interventions

Combination 70% FDBA and 30% DFDBA DEVICE

A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA

Also known as: FDBA/DFDBA

FDBA/DFDBA Control Group

OsteoGen Plug DEVICE

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)

Also known as: Osteogen

Osteogen Test Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged 18 to 89
• One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
• A dental implant is indicated and treatment planned to replace the missing tooth
• Site has adequate restorative space for a dental implant-retained restoration
• Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
• Site has a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and nonpregnant women of child-bearing potential.
• Patients are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day (less than or equal to 10 cigarettes per day)

You may not qualify if:

• Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
• Patients who will not cooperate with the follow-up schedule.
• Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
• Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
• Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
• Smokers who smoke \>10 cigarettes per day (more than 10 cigarettes per day)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio School of Dentistry

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Brian Mealey, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Mealey, DDS, MS

CONTACT

210-567-3589; mealey@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blind to the material used for their bone graft. Histomorphometric examiners will be blinded when the bone cores are evaluated for % vital bone, % residual graft and % CT/other.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-study-site parallel-arm randomized controlled clinical trial

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The investigators plan to publish the data once the study is complete and data analysis has occurred. Summary results will also be reported on ClinicalTrials.gov at least one year after primary completion date is reached.

Locations

US (1)